| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| MODERATE TO SEVERE PAIN FOLLOWING DYSMENORRHOEA |
| DOLOR MODERADO A SEVERO PARA DISMENORREA |
|
| E.1.1.1 | Medical condition in easily understood language |
| MODERATE TO SEVERE PAIN |
| DOLOR MODERADO A SEVERO |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| The main objective is to evaluate the analgesic efficacy of fixed-dose combination of ibuprofen and acetaminophen , oral administration , compared to the individual components and placebo in patients with moderate to severe primary dysmenorrhea . |
| El objetivo principal consiste en evaluar la eficacia analgésica de la combinación a dosis fijas de ibuprofeno y paracetamol, en administración oral, frente a los componentes por separado y placebo, en pacientes con dismenorrea primaria moderada a intensa. |
|
| E.2.2 | Secondary objectives of the trial |
| The secondary objective the safety and tolerability of all preparations will be evaluated. |
| El objetivo secundario se evaluará la seguridad y la tolerabilidad de todos los preparados. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1) Able to understand and sign the informed consent before participating in the study and willing to comply with all procedures and scheduled visits and to collect the information required by the protocol.
2) Women aged ? 18 years .
3) Primary dysmenorrhea with moderate to severe pain reaching a highest score of 40 mm Visual Analog Scale (VAS > 40 mm )
4) At least 4 painful menstrual cycles in the past six months , which have required pain medication .
5 ) regular menstrual cycles (28 ± 7 days).
6) Good general condition ( in the investigator's opinion), no clinically significant changes in clinical history, physical examination or laboratory tests .
7) Commit to use , in the investigator , a reliable method of contraception mind and be willing to continue that birth control throughout the study .
8) You agree not to take painkillers except for the protocol defined as rescue medication during the treatment period , until past 72 hours after administration of the first dose of study medication in each of the four study periods . |
1) Capaces de entender y firmar el consentimiento informado antes de participar en el estudio y dispuestas a cumplir con todas las visitas y los procedimientos programados y de recoger la información que requiere el protocolo.
2) Mujeres de edad ? 18 años.
3) Dismenorrea primaria con dolor de moderado a intenso alcanzando una puntuación mayor de 40 mm en la Escala Analógica Visual (EVA > 40 mm)
4) Al menos 4 ciclos menstruales dolorosos en los 6 meses anteriores, que hayan requerido medicación analgésica.
5) Ciclos menstruales regulares (28 ± 7 días).
6) Buen estado de salud general (en opinión del investigador), sin alteraciones clínicamente significativas en la historia clínica, en el examen físico o en las pruebas analíticas.
7) Comprometerse a utilizar, en opinión del investigador, un método de anticoncepción fiable y estar en disposición de continuar con ese método anticonceptivo durante todo el estudio.
8) Que acepten no tomar analgésicos a excepción de los que el protocolo define como medicación de rescate durante el período de tratamiento, hasta pasadas 72 horas tras la administración de la primera dosis de la medicación del estudio en cada uno de los cuatro periodos del estudio. |
|
| E.4 | Principal exclusion criteria |
1) History of allergy or hypersensitivity to the study medication, rescue medication or other nonsteroidal antiinflammatory drugs (NSAIDs), paracetamol or aspirin, or any of its excipients.
2) History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic edema.
3) a history of peptic ulcer, gastrointestinal disorders NSAIDs, gastrointestinal bleeding or other active bleeding.
4) renal failure, liver or moderate to severe heart.
5) bleeding diathesis and other coagulation disorders.
6) uncontrolled epilepsy.
7) Crohn's disease or ulcerative colitis.
8) medical history of infection with Human Immunodeficiency Virus (HIV) or any serious immunocompromised state.
9) History of any type of malignancy during the five years prior to entry into this study.
10) history of drug dependence or alcohol abuse. For the purposes of the study, alcohol dependence is defined as follows: average weekly consumption> 21 units (men) and> 14 units (women), or average daily consumption> 3 units (men) and> 2 units (women ) (One unit corresponds to approx. 125 ml of wine, 200 ml of beer, 25 ml of spirits).
11) patients unable to abstain from alcohol, psychotropic drugs or sedatives (eg benzodiazepines) or other banned drugs as related below for 48 hours or 5 half-lives (whichever is longer) before the start of surgery and for 24 hours after administration of study medication. The prohibited drugs are: different analgesics study medication, anticoagulants, thrombolytics and antiplatelet agents, corticosteroids, MAO inhibitors, anticonvulsants, antipsychotics, inhibitors of serotonin reuptake and tricyclic antidepressants, lithium, methotrexate, sulfonamides.
12) Patients who have received an analgesic, anti-inflammatory, antispasmodic or other treatment for dysmenorrhea within 6 hours before taking the study medication
13) who received an experimental drug or used an experimental medical device within 30 days prior to screening.
14) pregnant or lactating women.
15) History of any disease or condition that, at the discretion of the investigator, would constitute a risk to the patient or alter the results of the study (eg patients with acute pain from any other source or location).
16) They may not meet the requirements of the study or in the investigator's opinion should not participate. |
1) Antecedentes de alergia o hipersensibilidad a la medicación del estudio, la medicación de rescate o a cualquier otro antiinflamatorio no esteroideo (AINE), paracetamol o al ácido acetilsalicílico, o a alguno de sus excipientes.
2) Antecedentes de asma, broncoespasmo, rinitis aguda, pólipos nasales, urticaria o edema angioneurótico.
3) Antecedentes de úlcera péptica, trastornos gastrointestinales por AINE, hemorragia gastrointestinal u otras hemorragias activas.
4) Insuficiencia renal, hepática o cardiaca de moderada a grave.
5) Diátesis hemorrágica u otros trastornos de la coagulación.
6) Epilepsia no controlada.
7) Enfermedad de Crohn o colitis ulcerosa.
8) Antecedentes médicos de infección por el Virus de la Inmunodeficiencia Humana (VIH) o cualquier estado inmunocomprometido grave.
9) Antecedentes de cualquier tipo de neoplasia durante los 5 años anteriores a la entrada en este estudio.
10) Antecedentes de dependencia de drogas de abuso o alcohol. A efectos del estudio, la dependencia de alcohol se define de la siguiente manera: consumo semanal promedio >21 unidades (hombres) y >14 unidades (mujeres), o consumo diario promedio de >3 unidades (hombres) y >2 unidades (mujeres) (Una unidad corresponde a aprox. 125 ml de vino, 200 ml de cerveza, 25 ml de licores).
11) Pacientes incapaces de abstenerse de consumir alcohol, psicofármacos o sedantes (p.ej. benzodiacepinas) u otros medicamentos prohibidos como los relacionados más abajo durante 48 horas o 5 semividas (lo que sea más prolongado) antes del inicio de la cirugía y durante las 24 horas siguientes a la administración de la medicación del estudio. Los medicamentos prohibidos son los siguientes: analgésicos diferentes de la medicación de estudio, anticoagulantes, trombolíticos y antiagregantes plaquetarios, corticoesteroides, Inhibidores de la MAO, antiepilépticos, antipsicóticos, inhibidores de la recaptación de serotonina y antidepresivos tricíclicos, litio, metotrexato, sulfonamidas.
12) Pacientes que hayan recibido algún analgésico, antiinflamatorio, antiespasmódico u otro tratamiento para la dismenorrea en las 6 horas previas a tomar la medicación de estudio
13) Que hayan recibido un fármaco experimental o usado un dispositivo médico experimental en el plazo de los 30 días previos a la selección.
14) Mujeres embarazadas o en período de lactancia.
15) Antecedentes de cualquier enfermedad o trastorno que, a criterio del investigador, pudiera constituir un riesgo para la paciente o alterar los resultados del estudio (p.ej. pacientes con dolor agudo de cualquier otro origen o localización).
16) Que no puedan cumplir con los requisitos del estudio o que en opinión del investigador no deben participar. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary endpoint will be the reduction of pain at 6 h of initiation of treatment , measured in terms of pain intensity difference (PID ) at each point of observation the first 6 hours ( PID0-6h ) and pain relief Total ( TOTPAR0-6h ) until 6 hours post - dose as the VAS score ( 0-100). |
| La variable principal del estudio será la disminución del dolor a las 6 h de inicio del tratamiento, medida en términos de diferencia de intensidad del dolor (PID) en cada punto de observación las primeras 6 horas (PID0-6h) y el alivio del dolor total (TOTPAR0-6h) hasta las 6 horas post-dosis según la puntuación de la EVA (0?100). |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
?TOTPAR0-12, TOTPAR0-24h, SPID0-6h, SPID0-12h, SPID0-24h
? rate of use of rescue medication ,
? time to meaningful relief ,
? pain relief at each point of time, total pain relief at 6 ,
? patient global assessment |
?TOTPAR0-12, TOTPAR0-24h, SPID0-6h, SPID0-12h, SPID0-24h
?tasa de uso de medicación de rescate,
?tiempo hasta alivio significativo,
?alivio del dolor en cada punto de tiempo, alivio del dolor total a las 6h,
?valoración global del paciente |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| LVLS |
| ULTIMA VISITA DEL ULTIMO PACIENTE |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
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